USA – The US Food and Drug Administration (FDA) has approved AbbVie’s Risankizumab (Skyrizi) for a third indication — treatment of moderately to severely active Crohn’s disease in adults — making it the first specific anti-interleukin-23 (IL-23) monoclonal antibody indicated for Crohn’s disease.

The safety and efficacy of Risankizumab in Crohn’s disease is supported by data from two induction clinical trials (ADVANCE and MOTIVATE) and one maintenance clinical trial (FORTIFY).

The maximum rate of serious adverse events in patients taking Skyrizi across both clinical trials was just 4 percent, which was lower than the placebo rate of 5.5 percent.

According to the FDA, common adverse events reported by Crohn’s disease patients treated with Risankizumab include upper respiratory infections, headache, fever, abdominal pain, back pain, joint pain and injection site reactions.

Since Skyrizi is indicated for patients who don’t experience improvement on Tumor Necrosis Factor (TNF) inhibitors, the drug’s biggest strength lies in its safety profile.

For the treatment of Crohn’s disease, Skyrizi is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.

Unlike Janus kinase (JAK) inhibitors like Pfizer’s Xeljanz and Eli Lilly’s Olumiant, which come with increased risk of heart attack, cancer, and blood clots, Skyrizi hasn’t been found to elevate the risks of these events.

“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” Marla Dubinsky, MD, gastroenterologist with the Mount Sinai Health System and co-director of the IBD Center at Mount Sinai, said in a news release from AbbVie.

This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease,” Dubinsky said.

For the treatment of Crohn’s disease, Skyrizi is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.

Skyrizi is already approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

Psoriatic arthritis is a type of inflammatory arthritis that occurs when the immune system attacks healthy tissue, resulting in joint pain, stiff joints, and fatigue.

If psoriatic arthritis is left untreated for long enough, the condition can result in irreversible joint damage.

AbbVie’s inexhaustible drug stock

Aside from Skyrizi, AbbVie has dozens of drug indications that are in different stages of development.

AbbVie’s next-generation immunology drugs Skyrizi and Rinvoq each have indications for Crohn’s Disease and ulcerative colitis that are either in phase 3 clinical trials or that have already been submitted to regulatory authorities.

Last month, the FDA approved Rinvoq for patients with active ankylosing spondylitis, a common form of arthritis. 

In March, Rinvoq won approval as a treatment for patients with moderately to severely active ulcerative colitis.

Bullishly, AbbVie and Genmab co-announced promising study results for their lymphoma treatment in April.

Overall, more than 63% of patients responded to the treatment. Their responses were durable for a year, as per Investors.com.

AbbVie is also testing a treatment for myelofibrosis, a rare form of bone marrow cancer. A midstage study suggests the combination has anti-fibrotic properties, meaning they may slow the rate of fibrosis, or scarring, in the lungs.

Approval could add up to billions of dollars in annual sales and could be approved this year or next year.

Thanks to recent regulatory approvals and more that are expected to come, AbbVie believes that Skyrizi and Rinvoq will generate more than US$15 billion in combined sales by 2025.

This would be more than triple the US$4.59 billion in combined sales that the two drugs produced last year.

Factoring in a 50%, or nearly US$9 billion, decline in Humira’s US sales by 2025 from biosimilar drug competition starting next year, Skyrizi and Rinvoq should be enough to replace the revenue loss from Humira.

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